MICRO LABS FDA Approval ANDA 211925

ANDA 211925

MICRO LABS

FDA Drug Application

Application #211925

Application Sponsors

ANDA 211925MICRO LABS

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORALEQ 12.5MG BASE;5MG0CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE
002TABLET;ORALEQ 25MG BASE;10MG0CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE

FDA Submissions

UNKNOWN; ORIG1AP2022-02-02STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

MICRO LABS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211925
            [companyName] => MICRO LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE","activeIngredients":"AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE","strength":"EQ 12.5MG BASE;5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE","activeIngredients":"AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE","strength":"EQ 25MG BASE;10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/02\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-02-02
        )

)

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